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Section 1157 Final Rule – New Requirements and Model Notices

on Friday, 31 May 2024 in Health Law Alert: Erin E. Busch, Editor

On May 6, 2024, the Office for Civil Rights (“OCR”) published a final rule entitled, “Nondiscrimination in Health Programs and Activities” (the “Final Rule”), regarding Section 1557 of the Affordable Care Act (“ACA”).  Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in specified health programs or activities, including those that receive federal financial assistance.  The Final Rule is effective July 5, 2024. The first Section 1557 final rule was published by the Obama administration in 2016 and a second final rule published in 2020 by the Trump administration rescinded significant portions of the 2016 rule.  The 2024 Final Rule restores and expands upon many of the requirements set forth in the 2016 final rule. 

Expanded Scope

The Final Rule expands the number of affected health programs and activities to which the nondiscriminatory provisions apply.  These include all health programs and activities supported directly or indirectly with federal financial assistance from the U.S. Department of Health and Human Services (“HHS”), such as Medicare and Medicaid, and those administered by HHS.  The Final Rule also applies to federally-facilitated marketplaces and state-based marketplaces.  OCR changed its previous interpretation and now includes Medicare Part B as a program receiving federal financial assistance.  Covered entities include hospitals, health clinics, health insurance issuers, state Medicaid agencies, community health centers, physicians’ practices, and home health care agencies.  While the Final Rule expands the scope of affected health programs and activities, it does not apply to employment practices, including the provision of employee health benefits.  For more information on the impact of the rule to benefits, click here.

Individuals with Limited English Proficiency

Covered entities must take reasonable steps to provide meaningful access by individuals with limited English proficiency (“LEP”), including through telehealth services.  Such steps include providing notices that language assistance services will be provided free of charge when necessary to comply with the rule and adopting procedures describing the process for providing language assistance services to individuals with LEP.  Language assistance services include providing a qualified translator in-person or remotely for oral and written translation and the use of services of multilingual staff.  The Final Rule provides flexibility in adopting procedures, taking into account factors such as the nature and importance of the health program and the communication at issue. 

Individuals with Disabilities

The Final Rule requires effective communication, including through appropriate auxiliary aids and services; establishes standards for accessibility of buildings and facilities; requires accessibility for health programs provided electronically; and requires modifications to policies, procedures, and practices to provide individuals with disabilities access to health programs and activities.

Discrimination on the Basis of Sex

The Final Rule defines sex discrimination as including sexual orientation, gender identity, sex characteristics (including intersex traits), pregnancy or related conditions, and sex stereotypes.  The Final Rule does not require a specific standard of care or course of treatment for any minor or adult patient. Providers do not have an affirmative obligation to offer any health care that providers do not think is clinically appropriate or if religious or conscience protections apply. This includes gender affirming care. OCR points to HHS’ general practice of deferring to a clinician’s judgment about whether a particular service is medically appropriate for an individual.

The Final Rule does not require covered entities, including state Medicaid agencies, to cover a particular health service for the treatment of gender dysphoria for any minor or adult. The Rule, however, prohibits health insurance issuers, state Medicaid agencies, and other covered entities from excluding categories of services in a discriminatory manner. Coverage must be provided in a neutral and nondiscriminatory manner.

Although the Final Rule protects those with pregnancy or related conditions, the Final Rule clarifies that a provider does not engage in discrimination prohibited by Section 1557 if the provider declines to provide abortions based on religious or conscience objections, based on a professional or business judgment about the scope of the services the provider wishes to offer, or for any other nondiscriminatory reason.  OCR emphasizes that the ACA provides that “[n]othing in this Act shall be construed to have any effect on Federal laws regarding—(i) conscience protection; (ii) willingness or refusal to provide abortion; and (iii) discrimination on the basis of the willingness or refusal to provide, pay for, cover, or refer for abortion, or to provide or participate in training to provide abortion.[1]

Patient Care Decision Support Tools

The Final Rule prohibits discrimination against individuals through the use of patient care decision support tools, including automated or non-automated tools, mechanisms, methods or technology, such as artificial intelligence or clinical algorithms.  Providers have an ongoing responsibility to identify use of patient care decision support tools that directly measure race, color, national origin, sex, age, or disability, and to make reasonable efforts to mitigate the risk of discrimination from the use of such tools.

Additional Key Requirements

Covered entities with fifteen (15) or more employees are required to have a civil rights grievance procedure and an employee designated to coordinate compliance for the Final Rule.  Covered entities must provide training to relevant employees on their Section 1557 policies and procedures.  “Relevant employees” are defined as permanent and temporary employees whose roles and responsibilities entail interacting with patients and members of the public; making decisions that directly or indirectly affect patients’ health care, including the covered entity’s executive leadership team and legal counsel; and performing tasks and making decisions that directly or indirectly affect patients’ financial obligations, including billing and collections.

Model Notices

The Final Rule requires covered entities to provide and post notices informing individuals of their civil rights under Section 1557.  Covered entities must also provide a notice informing individuals that free language assistance services and auxiliary aids and services are available to protect individuals with LEP and individuals with disabilities. The notice must be provided in the top fifteen (15) languages spoken by individuals in the relevant state(s) where the entity operates. OCR has provided sample notices in English and forty-seven (47) other languages.  Covered entities also may create their own notices.  The Final Rule contains specific requirements for how, when, and where notices must be provided and posted.

Dates for Compliance

The Final Rule provides staggered dates for compliance with certain provisions, but covered entities must comply with all provisions within one (1) year of the effective date: 

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